A Randomized, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
This Phase 2 pilot study assessed the safety and efficacy of MDMA-assisted therapy in 10 people with chronic, treatment-resistant PTSD, comparing the effects of low and full dose MDMA. The first two subjects were enrolled in the open-label full dose lead-in with 125 mg of MDMA, followed 1.5 to 2.5 hours later by a supplemental half-dose of 62.5 mg of MDMA, administered with manualized therapy. The remaining eight subjects enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25 mg MDMA, with a supplemental dose of 12.5 mg MDMA) or a fully active dose of MDMA (125 mg, with a supplemental dose of 62.5 mg MDMA) administered with therapy during two Experimental Session, each lasting six to eight hours and scheduled three to five weeks apart. The extent of PTSD symptoms was assessed at baseline and two months after the second experimental session using the Clinician Administered PTSD Scale for DSM-IV (CAPS-4). Subjects who enrolled in Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study and complete open-label Experimental Sessions with the fully active dose of MDMA on the same schedule as Stage 1.
The change in CAPS-4 from baseline to primary endpoint was -34.6 (SD: 16.29) for participants in the full dose group, compared to -9.0 (SD: 15.62) for participants in the 25 mg group. No serious adverse events occurred and MDMA was well-tolerated by participants.